Patient Information Leaflet

Quetiapina Krka 50 mg Extended-Release Tablets EFG

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Quetiapina Krka is and what it is used for

2.What you need to know before you start taking Quetiapina Krka

3.How to take Quetiapina Krka

4.Possible side effects

5.Storage of Quetiapina Krka

6.Contents of the pack and additional information

Quetiapina Krka contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapina Krka may be used to treat several conditions, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: for which you may feel sad. You may find that you feel depressed, guilty, lack energy, have a loss of appetite, or cannot sleep.
• Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, which may include being aggressive or violent.
• Schizophrenia: for which you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When using Quetiapina Krka to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medication that is being used to treat this condition.

Your doctor may continue to prescribe Quetiapina Krka even if you feel better.

Do not takeQuetiapina Krka:

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any of the following medicines:

-some HIV medicines

-azole-type medicines (for fungal infections)

-erythromycin or clarithromycin (for infections)

-nefazodone (for depression).

If you are unsure, consult your doctor or pharmacist before taking this medicine..

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Krka if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness, heart inflammation, or if you are taking any medicine that may affect your heart rhythm.
• You have low blood pressure.
• You have had a stroke, especially if you are an older patient.
• You have liver problems.
• You have had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking this medicine.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• You are an older patient with dementia (loss of brain function). If so, do not take quetiapine, because the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, death in these patients.
• You are an older patient with Parkinson's disease/parkinsonism.
• You or a family member has a history of blood clots, as these medicines have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing is interrupted by short periods of time during normal sleep (called "sleep apnea") and are taking medicines that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.

Inform your doctor immediately if you experience any of the following after taking quetiapine::

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in older patients.
• Seizures (convulsions).
• Painful and prolonged erections (priapism).
• Fast and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this may be the result of a low white blood cell count that may require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medicines take time to take effect, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 years with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe cutaneous adverse reaction (SCAR)

Severe cutaneous adverse reactions (SCARs), which may put your life at risk or be fatal, have been reported very rarely with quetiapine treatment. These have manifested frequently by:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe condition that causes extensive skin peeling.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including eosinophilia and elevated liver enzymes).
• Acute generalized pustular psoriasis (AGPP), small pus-filled blisters.
• Multiforme erythema (EM), a skin rash with irregular red patches that itch.

Stop using Quetiapina Krka if you develop these symptoms and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking quetiapine. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapine is not used in children and adolescents under 18 years.

Other medicines and Quetiapina Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take quetiapine if you are using any of the following medicines:

• Some HIV medicines.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Inform your doctor if you are taking any of the following medicines:

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Before stopping any of your medicines, consult your doctor first.

Taking Quetiapina Krka with food, drinks, and alcohol

• This medicine may be affected by food, so take your tablets at least one hour before a meal or before bedtime.
• Be careful about the amount of alcohol you drink. This is because the combined effect of this medicine and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during pregnancy unless you have discussed it with your doctor. Quetiapina Krka should not be taken if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used Quetiapina Krka in the last trimester (last three months of their pregnancy): shakiness, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machines

Quetiapina Krka may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying illness, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Quetiapina Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medicine.

This medicine contains 8.44 mg of sodium (main component of table salt/for cooking) in each 50 mg prolonged-release tablet. This is equivalent to 0.42% of the recommended daily maximum sodium intake for an adult.

Effect on drug detection tests in urine

If you are undergoing a drug detection test in urine, taking quetiapine may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs, but will normally be between 150mg and 800mg.

• You will take your tablets once a day.
• Do not break, chew, or crush the tablets.
• Swallow your tablets whole with the help of water.
• Take the tablets without food (at least one hour before a meal or before going to bed, your doctor will tell you when).
• Do not take grapefruit juice while taking Quetiapina Krka. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may change your dose.

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

Quetiapina Krkashould not be used in children and adolescents under 18 years old.

If you take moreQuetiapina Krkathan you should

If you take moreQuetiapina Krkathan your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina Krka tablets with you.

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeQuetiapina Krka

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment withQuetiapina Krka

If you stop taking Quetiapina Krka abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common side effects(may affect more than 1 in 10 people):

• Dizziness (which could lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take this medicine) (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking the medicine) include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremor, feeling restless or muscle stiffness without pain.
• Changes in the amountof certain fats (triglycerides and total cholesterol).

Common side effects(may affect up to 1 in 10 people):

• Fast heart rate.
• Feeling like your heart is beating strongly, rapidly, or irregularly.
• Constipation, indigestion.
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause you to feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in measurable liver enzymes in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:
• Men and women experiencing breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

Uncommon side effects(may affect up to 1 in 100 people):

• Seizures or convulsions.
• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change seen in the ECG in heart electrical activity (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which could lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare side effects(may affect up to 1 in 1000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowish discoloration of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased fat around your abdomen, decreased good cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar levels.
• Combination of fever, flu-like symptoms, sore throat, or any other infection with low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Very rare side effects(may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe skin blistering, mouth, eyes, or genital area (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Side effects of unknown frequency (cannot be estimated from available data)

• Rashes on the skin with irregular red spots (erythema multiforme). See section 2.
• Appearance of rapid areas of red skin with small pustules (small blisters filled with white/yellow liquid called pustulosis exanthematosa aguda generalizada (PEAG). See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS) consisting of flu-like symptoms with rash, fever, swollen lymph nodes, and altered blood test results (including increased white blood cell count and liver enzymes). See section 2.
• Side effects may occur in newborn babies of mothers who have taken Quetiapina Krka during pregnancy.
• Haemorrhage.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of the blood vessels), often with skin rash with small red or purple spots.

The class of medicines to which Quetiapina Krka belongs can cause heart rhythm problems that can be serious and, in severe cases, fatal.

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in men and women, breast swelling and unexpected milk production.
• In women, not having a menstrual period or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Side effects in children and adolescents.

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or have not been seen in adults:

Very common side effects(may affect more than 1 in 10 people):

• Increased amount of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:
• Both in boys and girls, breast swelling and unexpected milk production.
• In girls, not having a menstrual period or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, agitation, feeling tired or muscle stiffness without pain.
• Increased blood pressure.

Common side effects(may affect up to 1 in 10 people):

• Sensation of weakness, fainting (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and the packagingafter CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofQuetiapineKrka

• The active ingredient is quetiapine. Each prolonged-release tablet contains 50 mg of quetiapine (as quetiapine hemifumarate).
• The other components are: hypromellose, lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate and magnesium stearate in thenucleuse hypromellose, titanium dioxide (E171) and macrogol 400 in the coating. See section 2“Quetiapine Krka contains lactose and sodium”.

Appearance of the product and contents of the pack

The prolonged-release tablets of 50 mg are white to almost white, capsule-shaped, slightly biconvex, coated with a film with beveled edges and engraved with “50”on one of the faces. Dimensions of the tablet: 16.2 mm in diameter and a 4.0 – 5.2 mm in thickness.

Quetiapine Krka50 mg prolonged-release tabletsare available in packs containing 10, 30, 50, 60, 90 and 100 prolonged-release tablets in OPA/Al/PVC-Al blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz‑Lohmann‑Str. 5, 27472 Cuxhaven, Germany

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKAPharmaceuticals, S.L., C/Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in themember states of the European Economic Area with the following names:

Last update of this leaflet: December 2021

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/